Abzena · 3 hours ago
QC Manager, Analytical
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $140K/yr
7+ years expAbzena is a company dedicated to quality excellence in the development of biologics and bioconjugates. The Manager of Quality Control, Analytical is responsible for overseeing daily QC lab operations, method qualifications, and process improvement while supervising and mentoring QC Associates.
BiopharmaBiotechnologyLife SciencePharmaceutical
Responsibilities
Provides supervision to QC staff to perform duties in support of manufacturing, in support of the facility, and as necessary development activities; ensures appropriate level loading and communication of priorities
Responsible for optimization and operation of the quality control laboratory in a biopharmaceutical manufacturing setting, including all related infrastructure, documentation, equipment validation and analyst training
Develops, implements, and maintains quality control systems in accordance with cGMP requirements
Develops and mentors staff to improve individual and departmental performance
Provides daily oversight of manufacturing support testing for multiple projects and related stability studies
Manages all aspects of Quality Control (QC), in support of Abzena GMP projects, and in full compliance with established cGMP and Abzena requirements
Leads the scheduling, level loading and forecasting sample receipt and testing for the analytical laboratory
Oversees and manages processes for the following:
Test method verification, qualification, validation and/or transfer activities between Assay Development and QC laboratories
Assay Performance Qualification and Continued Assay Verification activities associated with QC laboratory testing
Maintenance, calibration and qualification of laboratory instruments and equipment
Ensuring adequate training (skills-based, cGMP and safety) of QC scientists and associates within the department
Raw material, in-process, product release, stability and environmental testing
Investigation of laboratory non-conformances (events, deviations, and invalid assays)
Strategic capital projects for the QC labs
Conducts investigations and resolves complex and non-routine issues
Interact closely with Manufacturing and R&D Departments
Provides expertise in troubleshooting complex laboratory issues and demonstrates strong reasoning skills in support of ongoing laboratory investigations
Manages cGMP release and stability testing at Abzena, SS and contract testing laboratories
Manages the implementation, qualification, validation and transfer of client’s product specific methods
Authors and reviews Quality Control Standard Operating Procedures (SOPs), Assay Qualification and Stability Protocols
Reviews and approves Standard Test Methods, Technical and Stability Reports
Assists in investigation and review of deviations, change controls, CAPAs, OOT/OOS thru GMP Quality System
Maintains and monitors client’s product stability programs
Qualification
Required
B.S. or higher degree in Biology, or related Life Sciences degree with at least 7+ years of experience working under GMP and at least 0-3 years managerial experience
Practical knowledge in all aspects of product development from investigational phase to commercial launch including method development, tech transfer, phase appropriate validation and CMC submissions
Experience in the establishment and operation of QC laboratories in a GMP regulated environment
Extensive knowledge of U/HPLC, UV-Vis, FTIR, SDS-PAGE, ELISA, CE, and compendial assays
Knowledge of regulatory guidelines relating to method qualification and validation
Proven leadership and motivational capabilities
Experience with Data Trending and control chart interpretation
Preferred
Knowledge with managing stability programs is desirable
Company
Abzena
Abzena is a biotechnology company that offers biologic and ADC products from concept to clinic.
501-1000 employees
H1B Sponsorship
Abzena has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$139.44MKey Investors
Biospring PartnersProVen VCT
2022-03-31Private Equity· $65M
2020-07-28Private Equity· $10M
2018-08-16Acquired
Leadership Team
Geoffrey Glass
Chief Executive Officer
Daniel Giroux
Vice President, Development
Recent News
Genetic Engineering News
2025-11-08
2025-10-24
Company data provided by crunchbase